The FDA has issued a Class 1 Recall for a wide range of GemStar Infusion intravenous machine models, as reported by beckersasc.com. The recalled models, according to the American Society of Anesthesiologists, suffered issues wherein a drop in the battery voltage rendered the device unusable; the malfunction can also erase the history logs of the device’s on-board computer. The devices, which were manufactured between 1999 and 2013, are critical to patient care; an interruption in the service the machines provide can result in serious injury and death.
GemStar was aware of the product’s malfunctions, as it noted in a letter earlier this year. However, the company did not issue a voluntary recall, but instead advised consumers to closely monitor the machines for any errors, as well as contact GemStar for battery replacements.
Our firm has handled many cases involving product recalls, so we know how dangerous and devastating a defective product can be. The FDA was right to issue the recall of the intravenous machines, as the machines’ critical importance to the medical industry demands that they be working properly all the time.
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